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Effect of Real-world Tight Control Management of Inflammatory Bowel Disease

NCT03633669 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-08-15

No results posted yet for this study

Summary

Inflammatory bowel disease, which includes Crohn's disease and ulcerative colitis, is a condition that causes inflammation in the gastrointestinal tract. The disease goes through periods of remission and flare. Biomarkers such as fecal calprotectin have been proposed as a tool to monitor disease activity. Fecal calprotectin is a test that measures the amount of inflammation in the stool. Monitoring fecal calprotectin levels can assist gastroenterologists in making decisions regarding patients' IBD treatment such as whether to increase the dose of medications. A recent study showed that frequent measurement of fecal calprotectin every 3 months, also called the tight-control strategy, was associated with improved clinical outcomes in IBD patients. The purpose of this study is to assess whether the tight-control monitoring strategy, which includes fecal calprotectin monitoring every 3 months, improves clinical outcomes in IBD when performed in the real world compared to routine clinical practice.

Conditions

  • Inflammatory Bowel Diseases

Interventions

DIAGNOSTIC_TEST

Fecal calprotectin

Testing every 3 months

OTHER

Routine care

As per treating gastroenterologist

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2019-12-31
Completion
2019-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03633669 on ClinicalTrials.gov